Bio Process Operator Lead Resume Summary
Resume:
PAULETTE ROBINSON
BIO PROCESS OPERATOR LEAD
CONTACT
*************@******.***
Windsor Mill, MD 21244
CAREER OBJECTIVE
Detail-oriented professional with excellent communication, interpersonal and creative thinking skills. Aiming to leverage my abilities to successfully fill the vacancy at your company. Frequently praised as hardworking by my peers, I can be relied upon to help your company achieve its goals.
EXPERIENCES
Central Service Technician IV
Catalent
October 2022-Present
I am responsible for supporting the manufactured process in Central Services, through the application of broad knowledge of theories and principles utilize to solve operational as well as routine tasks in the production of bulk biologics from microbial and cell culture system for Phase 1&2 and commercial GMP manufacturing.
Key Responsibility:
Attend meetings as necessary to facilitate area needs based on changes, etc (lean activities)
Perform timely consumption of materials and completion of quality documentation in appropriate systems.
Identify deviations and aid in investigations/root cause analysis. Work to complete documentation of deviations, change controls, CAPA, events in appropriate systems to meet set deadlines. Actively coordinate/ direct day to day activities of both media & buffer prep operations.
Create and Coordinate Central Services schedule to meet the demands of Upstream & Downstream manufacturing.
Provide thorough review/input of documents SMP’s Protocols & SOP’s .
Monitor Technician training for completeness and discipline / encourage Techs to reach set completion rate/date.
Administer company policies that directly affect subordinate employees.
Assign tasks and provide guidance to employees according to established policies
January 2022 – October 2022
Bio Processor Lead
Emergent BioSolutions, Baltimore, MD
- Operated pharmaceutical manufacturing equipment such as: autoclaves, parts washers, filter integrity testers, incubators, single use and stainless steel bioreactors.
- Was able to perform and monitor critical processes, execute routine validation protocols.
- Identified and troubleshooted unexpected events on equipment and systems used in manufacturing.
- Executed logbooks, forms, solution prep and batch records according proper GMP and site quality standards. In addition, performed department review of logbooks and forms.
- Assisted and informed supervisor on progress of projects, transfer of data and process details.
- Assisted and coached other manufacturing process teams with cross functional tasks to complete manufacturing team objectives within site.
June 2018 - September 2021
Bulk Formulation Operator
BD- Becton Dickinson, Hunt Valley, MD
Weighed and measured materials to create uniform products.
Performed simple analytical tests involving pH, conductivity, and absorbance.
Monitored gauges, meters, temperatures, pressures, and related control form media preps.
Used independent judgement in trouble shooting and problem solving under little/no supervision.
Handled hazardous waste as appropriate and assisted with inventory counting activities as required.
Was responsible for ensuring timely and accurate documentation of all manufacturing activities performed.
May had to provide training support for on-boarding and/or new procedures.
May 2016 - June 2018
Machine Operator
BD- Becton Dickinson, Hunt Valley, MD
- Performed work standards within a team setting to plan, perform and make decisions regarding the set up and operations of a variety of production equipment, including automated machine processes and controls to perform routine assembly-line production functions of filling, packing, assembling, labeling and inspecting media products.
- Assisted with clean up functions in sterilized areas.
- Ensured accurate documentation of all relevant quality, safety and maintenance documents.
-Identified, trouble shot and resolved basic issues associated with the machine performance and/or poor quality media.
June 2012 - May 2016
Packaging Operator
BD- Becton Dickinson, Hunt Valley, MD
Observed machine operations to ensure quality and conformity of filled and packaged products to standards.
Removed finished packaged items from machine and separate rejected items.
Performed production assignments that were moderately complex in nature.
Analyzed and evaluated charts and followed testing and inspection procedures.
Used mechanical aptitude required to control machine operations including minor equipment repairs and identifying and resolving equipment problems.
Maintained accurate records and logs in accordance with FDA, GMP's and ISO9000. Effectively worked in a team setting, supporting team goals and daily objectives.
April 2009 - December 2012
Lead Picker
Bertlmann, Baltimore, MD
Packed and unpacked items to be stocked on shelves in stockrooms, warehouses and storage yards.
Compared merchandise invoices to items actually received to ensure that shipments were correct ina high-volume environment for Aetna Insurance forms.
EDUCATION
June 1979
High School Diploma
Fredrick Douglas High School, Baltimore, MD
ADDITIONAL SKILLS
High-Volume Environments
Team Meetings
Policy and Procedure Explanations
Electronic Recordkeeping
Caregiver Relations
Fluid Measurement
Quality Patient Care
Patient Information
First Aid Certification
Biohazard Disposal
Room Cleaning and Restocking
Biological Specimen Handling
REFERENCES
References available upon request
Contact this candidate